MAUDE Adverse Event Report: CORIN MEDICAL CORMET; RESURFACING HIP SYSTEM

Model Number NOT PROVIDED

Device Problem Device Slipped (1584)

Patient Problem Failure of Implant (1924)

Event Date 06/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information, including device details, post primary and pre revision x-rays, operative notes, patient medical history and the explanted devices has been requested in order to progress with this investigation, and if received, will be provided in a supplemental report upon completion of the investigation.Upon receipt of the appropriate device details the relevant device manufacturing records will be identified and reviewed.

Event Description

Cormet revision after approximately 8 years due to loosening of the cup.

Manufacturer Narrative

(b)(4) final report.Additional information, including device details, post primary and pre revision x-rays, operative notes, patient medical history and the explanted devices were requested in order to progress with the investigation of this event.However, this information was not provided and thus there was only very limited information available for the investigation.The device details were not provided and thus the device manufacturing records could not be identified or reviewed.Based on the information provided, no further investigation can be conducted and thus corin now consider this case closed.However, should additional information be provided then this case may be re-opened for further investigation.

Event Description

Cormet revision after approximately 8 years due to loosening of the cup.

• Brand Name: CORMET
• Type of Device: RESURFACING HIP SYSTEM
• Manufacturer (Section D): CORIN MEDICAL; the corinium centre; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer (Section G): CORIN MEDICAL; the corinium centre; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer Contact: franck didier ; the corinium centre; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ ; 1285659866
• MDR Report Key: 7018385
• MDR Text Key: 91882027
• Report Number: 9614209-2017-00072
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NOT PROVIDED
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention